The EU Clinical Trials Register currently displays
34922
clinical trials with a EudraCT protocol, of which
5688
are clinical trials conducted with subjects less than 18 years old.
The register also displays information on
18700
older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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Objective: After 24 weeks, to assess the effect of the coadministration of sitagliptin100 mg q.d. and pioglitazone 30 mg q.d. compared to pioglitazone alone on HbA1c.

Objective: To assess the safety and tolerability of the coadministration of sitagliptin100 mg q.d. and pioglitazone 30 mg q.d.

E.2.2

Secondary objectives of the trial

In patients with T2DM with inadequate glycemic control:Objective: After 24 weeks, to assess the effect of the coadministration of sitagliptin100 mg q.d. and pioglitazone 30 mg q.d. compared to pioglitazone 30 mg q.d. alone on the 2-hour post prandial glucose (PPG) following a standard meal challenge.

Objective: After 24 weeks, to assess the effect of the coadministration of sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. compared to pioglitazone 30 mg q.d. alone on FPG.

Objective: After 1 week, to assess the effect of the coadministration of sitagliptin100 mg q.d. and pioglitazone 30 mg q.d. compared to pioglitazone 30 mg q.d. alone on FPG.

E.2.3

Trial contains a sub-study

No

E.3

Principal inclusion criteria

1. Patient has T2DM.2. Patient is a male or female and ≥18 years of age on day of signing informed consent.3. Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and post-study follow-up period.4. Patient is a male, or is a female who is highly unlikely to conceive, as indicated by at least one “yes” answer to the following questions:a. Patient is a male.b. Patient is a surgically sterilized female.c. Patient is a postmenopausal female ≥45 years of age with >2 years since lastmenses.d. Patient is a non-sterilized premenopausal female and (if sexually active) agrees touse 2 adequate methods of contraception to prevent pregnancy (either 2 barriermethods or a barrier method plus a hormonal contraceptive method) and for14 days after the last dose of study medication.Note: Acceptable methods of birth control are: hormonal contraceptive,intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge,condom, or vasectomy.5. Patient understands the study procedures and agrees to participate in the study by giving written informed consent.Glycemic Entry Criteria6. Patient has not been on any oral antihyperglycemic medication or insulin therapyprior to screening (except as described below and in Section 2.3) and has a Visit 1/Screening Visit 1 HbA1c ≥8.0% and ≤12.0%.Note: Patients may participate who have < 4 weeks cumulative AHA therapy over thepast 2 years, and with no AHA treatment over the prior 4 months.

E.4

Principal exclusion criteria

Glucose Metabolism and Therapy Criteria1. Patient has a history of type 1 diabetes mellitus or history of ketoacidosis.2. Patient was on antihyperglycemic agent therapy (oral or insulin) within 4 monthsprior to screening.3. Patient was on > 4 weeks (cumulatively) of antihyperglycemic therapy over the prior 2 years.4. Patient has symptomatic hyperglycemia which the investigator assesses as requiring immediate initiation of antihyperglycemic therapy (i.e., without 2 week diet and exercise run-in period).Patients Requiring Specific Treatments5. Patient is on a weight loss program and is not in the maintenance phase or has started on a weight loss medication (e.g. orlistat or sibutramine) within the prior 8 weeks.

E.5 End points

E.5.1

Primary end point(s)

HbA1c

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

No

E.6.2

Prophylaxis

No

E.6.3

Therapy

No

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

No

E.6.7

Pharmacodynamic

No

E.6.8

Bioequivalence

No

E.6.9

Dose response

No

E.6.10

Pharmacogenetic

No

E.6.11

Pharmacogenomic

No

E.6.12

Pharmacoeconomic

No

E.6.13

Others

No

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

No

E.7.1.1

First administration to humans

No

E.7.1.2

Bioequivalence study

No

E.7.1.3

Other

No

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

No

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

No

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

No

E.8.1.3

Single blind

No

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

No

E.8.1.7

Other

No

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

No

E.8.2.2

Placebo

Yes

E.8.2.3

Other

No

E.8.3

The trial involves single site in the Member State concerned

No

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

3

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

E.8.7

Trial has a data monitoring committee

No

E.8.8

Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

1

E.8.9.1

In the Member State concerned months

5

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

1

E.8.9.2

In all countries concerned by the trial months

5

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

No

F.1.1.1

In Utero

No

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

No

F.1.1.3

Newborns (0-27 days)

No

F.1.1.4

Infants and toddlers (28 days-23 months)

No

F.1.1.5

Children (2-11years)

No

F.1.1.6

Adolescents (12-17 years)

No

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

No

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Information not present in EudraCT

F.3.3.1

Women of childbearing potential not using contraception

No

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

No

F.3.3.4

Nursing women

No

F.3.3.5

Emergency situation

No

F.3.3.6

Subjects incapable of giving consent personally

No

F.3.3.7

Others

No

F.4 Planned number of subjects to be included

F.4.1

In the member state

36

F.4.2

For a multinational trial

F.4.2.1

In the EEA

70

F.4.2.2

In the whole clinical trial

362

F.5

Plans for treatment or care after the subject has ended the participation in the trial
(if it is different from the expected normal treatment of that condition)

see protocol

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned